At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 919 enrolled
Drug / intervention
Obeticholic acid (10 mg) +2 moredrug
Likely dose
Obeticholic acid (10 mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
In Brief
A Phase 3 clinical trial evaluating Obeticholic acid (10 mg), Obeticholic acid (10 mg to 25 mg), and 1 other intervention for Compensated Cirrhosis and Nonalcoholic Steatohepatitis. Completed, enrolled 919 participants across 192 sites in 12 countries.
Detailed Summary
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, France, Germany, Hungary, New Zealand, Poland, Puerto Rico, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartAug 2017
First PostedFeb 2018
Primary CompletionSep 2022
TodayJul 2026
First PostedFeb 20, 2018
Enrollment StartAug 30, 2017
Primary CompletionSep 8, 2022
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 8.4 years ago
Interventions
Obeticholic acid (10 mg)drug
Tablets administered orally once daily.
Obeticholic acid (10 mg to 25 mg)drug
Tablets administered orally once daily.
Placebodrug
Tablets administered orally once daily.